Macfarlan Smith Limited
⚠️ Moderate Risk
FEI: 3002807530 • Edinburgh • UNITED KINGDOM
FEI Number
3002807530
Location
Edinburgh
Country
UNITED KINGDOMAddress
10 Wheatfield Road, , Edinburgh, , United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2009 | 64CCS01APOMORPHINE HCL (EMETIC) | 223FALSE | Philadelphia District Office (PHI-DO) |
| 8/16/2006 | 60MCS28NALTREXONE HYDROCHLORIDE (ANALGESIC, NARCOTIC) | New York District Office (NYK-DO) | |
| 9/23/2003 | 60MDY20MORPHINE HYDROCHLORIDE (ANALGESIC, NARCOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/7/2003 | 64CCR01APOMORPHINE HCL (EMETIC) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/11/2003 | 61NRS82GALANTAMINE HYDROBROMIDE (ANTI-DEPRESSANT) | 72NEW VET DR | New York District Office (NYK-DO) |
| 2/6/2003 | 64CCS01APOMORPHINE HCL (EMETIC) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 1/6/2003 | 64CCS01APOMORPHINE HCL (EMETIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Macfarlan Smith Limited's FDA import refusal history?
Macfarlan Smith Limited (FEI: 3002807530) has 7 FDA import refusal record(s) in our database, spanning from 1/6/2003 to 10/28/2009.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Macfarlan Smith Limited's FEI number is 3002807530.
What types of violations has Macfarlan Smith Limited received?
Macfarlan Smith Limited has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Macfarlan Smith Limited come from?
All FDA import refusal data for Macfarlan Smith Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.